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Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Palo Alto Medical Foundation
ClinicalTrials.gov Identifier:
NCT00217958
First received: September 19, 2005
Last updated: October 27, 2014
Last verified: October 2014
History of Changes
  Purpose

To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma


Condition Intervention
Lung Diseases
Asthma
 Behavioral: SHS reduction intervention based on social cognitive learning theory

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Palo Alto Medical Foundation:
Study Start Date: May 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Secondhand tobacco smoke (SHS) exposure increases asthma morbidity in children. Efforts to reduce exposure have had mixed results. This study is a randomized controlled trial of an exposure reduction intervention, with objective feedback to parents on the child's exposure based on urine cotinine measurement, and counseling tailored to the child's specific exposure sources/locations and parental readiness to take specific actions to reduce exposure from each source/location. This trial involves 350 SHS-exposed children with persistent asthma, 3-12 years of age, receiving care from the Kaiser Health Care Program in Northern California. Primary outcomes over the 18 months of follow-up will be asthma acute care utilization and urine cotinine/creatine ratio. Changes in controller medication adherence will be evaluated using a pharmacy-based dispensing index.

DESIGN NARRATIVE:

Primary objective: To evaluate the efficacy of a behaviorally-based, cotinine-feedback-and-monitoring program designed to reduce SHS exposure in an 18-month randomized controlled trial (RCT) with 350 children with persistent asthma, 3-12 years of age, in comparison with usual medical care.

Secondary objectives: 1) to investigate the behavioral mechanisms that mediate between the intervention and associated improvements in asthma outcomes, and 2) to determine the influence of initial caregiver stage of change with regard to smoking practices on response to the intervention.

Hypotheses:

  1. Disease outcomes: A behaviorally-based, individually-tailored intervention that emphasizes SHS exposure reduction, provides sequential feedback to the parent on the child's urine cotinine level, and is tailored to the parent's stage of change with regard to smoking practices will be associated with decreased asthma crisis care utilization and improvements in secondary disease outcomes over an 18-month follow-up period when compared with usual medical care.
  2. ETS exposure: The SHS reduction intervention will be associated with lower SHS exposure at follow-up (assessed by urine cotinine/creatinine ratio), compared with usual medical care.
  3. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization.
  Eligibility
Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Age 3-12 years
  • Kaiser member for >= 1 year
  • >= 1 asthma care visit in prior year
  • Persistent asthma likely based on prior year:

Physician diagnosis code of persistent asthma OR >= 4 beta agonist (BA) dispensing events OR >= 4 Anti-inflammatory (AI) dispensing events

  • Secondhand smoke exposure by parent report.
  • Parent agrees to participate in a clinical trial of a smoke exposure reduction interventio
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217958

Sponsors and Collaborators
Palo Alto Medical Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sandra Wilson Res Inst, Palo Alto Med Fdn
  More Information

Publications:
Farber HJ, Wilson SR, Caine L, Bertorello L, Brown NL, Verghese S, Luna V, Quesenberry CP. Association between parent report of smoke exposure level, effect of smoke on child's asthma, and urine cotinine levels. Paper presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.
Wilson SR, Brown NL, Farber HJ, Luna V, Verghese S, Caine L, Bertorello L, Quesenberry CP. Sources of and caregiver readiness to reduce secondhand smoke (SHS) exposure of children with asthma. Poster presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00217958     History of Changes
Other Study ID Numbers: 295, R01HL070012
Study First Received: September 19, 2005
Last Updated: October 27, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on February 27, 2015